NCT00364403

Brief Summary

This study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

August 30, 2010

Status Verified

August 1, 2010

Enrollment Period

2.8 years

First QC Date

August 14, 2006

Last Update Submit

August 27, 2010

Conditions

OverweightPregnancy

Keywords

Glycemic indexGlycemic loadLow fatImpaired glucose toleranceLarge for gestational age infantExcessive body weight

Outcome Measures

Primary Outcomes (1)

  • Birth weight as assessed by z-scores

    At birth

Secondary Outcomes (8)

  • Maternal energy intake

    During pregnancy

  • Maternal weight gain

    During pregnancy

  • Maternal insulin resistance assessed by HOMA

    During pregnancy

  • Maternal metabolic syndrome components

    During pregnancy

  • Infant body composition (ponderal index, skinfold thickness)

    At birth

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Low glycemic load diet

Behavioral: Low glycemic load

2

ACTIVE COMPARATOR

Low fat diet

Behavioral: Low fat diet

Interventions

Low glycemic loadBEHAVIORAL

Provision of foods and dietary counseling to promote a low glycemic load diet

1
Low fat dietBEHAVIORAL

Provision of foods and dietary counseling to promote a low fat diet

2

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women with prepregnant or first trimester BMI equal to or greater than 25 kg/m2 and less than 45 kg/m2
  • Singleton pregnancy
  • Willing to consume the diets for duration of pregnancy
  • Participant to be at week 28 or less of pregnancy at baseline visit

You may not qualify if:

  • Smoking during pregnancy
  • Major medical illness (e.g., diabetes mellitus, hypertension, thyroid disease)
  • Patients taking prescription medication known to affect body weight
  • Alcohol consumption during pregnancy
  • Patients who declare their intention to deliver infants in the environment outside of Beth Israel Deaconess Medical Center, Boston
  • High level of physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Location

Related Publications (1)

  • Rhodes ET, Pawlak DB, Takoudes TC, Ebbeling CB, Feldman HA, Lovesky MM, Cooke EA, Leidig MM, Ludwig DS. Effects of a low-glycemic load diet in overweight and obese pregnant women: a pilot randomized controlled trial. Am J Clin Nutr. 2010 Dec;92(6):1306-15. doi: 10.3945/ajcn.2010.30130. Epub 2010 Oct 20.

    PMID: 20962162DERIVED

MeSH Terms

Conditions

OverweightGlucose Intolerance

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • David S Ludwig, MD, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Erinn Rhodes, MD

    Boston Children's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 14, 2006

First Posted

August 15, 2006

Study Start

February 1, 2007

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

August 30, 2010

Record last verified: 2010-08

Locations

US(2)